In a 12 to one vote, an FDA panel backed Shire's Firazyr (icatibant) for acute attacks of hereditary angioedema (HAE) in patients 18 years and older. The panel also said patients should be able to administer the drug themselves.
HAE is a rare and potentially deadly disease that causes swelling in the hands, feet, gastrointestinal tract and airways, according to Dow Jones. Panel members recommended that patients be able to inject themselves with Firazyr when they feel attacks coming on because it can be difficult to get to a healthcare provider quickly, and because few hospitals stock the drugs necessary to control HAE attacks. "Immediate access and self-administration reduces attack severity and duration," said Shire representative Marc Riedl, adding that quick dosing can also improve recovery time.
"Due to the unpredictable and potentially life-threatening nature of HAE attacks, we believe that self-administration of Firazyr can represent an effective and convenient treatment for patients to better manage their disease," said Sylvie Grégoire, president of Shire HGT. "We will continue to work closely with the FDA as it prepares to make its final decision on the Firazyr application."
In 2008, the FDA rejected Firazyr due to inconsistent trial data. The FDA will make a final ruling on the drug later this summer. If approved, analysts believe the drug could rack up $100 million in sales by 2015.
- here's Shire's release
- check out the article from Dow Jones